FDA Update Q3: End of September with Focus on Software
Summary of the summaries
You don't have time to study our summaries of the changes to the FDA guidance documents? Then at least read this short list to make sure you don't get in trouble with the FDA and don't do unnecessary work:
Reason and nature of the changes Most of the changes to the guidance documents have been made because the FD&C changed the classification of standalone software a medical device in 2016. A lot of software is now no longer classified as a medical device.
The FDA's interpretation of when software is a medical device The FDA has set out its view on how the FD&C should be interpreted in numerous documents. If you only want to read one document, make it the “Changes to Existing Medical Software Policies…”
No changes to the OTS guidance Save yourself the trouble of reading this document if you're short of time. The changes are very minor (editorial, definitions, references).
Significant changes to the clinical decision support guidance The FDA refers to SaMD in its IMDRF document. This means that two of the three categories in this document are excluded from the FD&Cs exemption. If you have a clinical decision support system, you should look at our article.
Medical device data systems (MDDS) differentiated between hardware and software The FD&C also changed the classification of MDDS. This doesn’t just affect software, some aspects also apply to medical imaging devices.
Guidance on mobile medical apps harmonized with the FD&C The guidance document has had to change a lot of examples. It is also interesting to note that it now talks about “software functions”, regardless of whether they are used on mobile devices or not.
If you have a bit more time, then read the following sections and the revised articles referenced there.
Please note that European authorities and notified bodies consult the FDA guidance documents, for example, to determine the state of the art. This affects, for example, the assessment of risks and corresponding measures set out by the FDA in the revised documents.